Unicon Pharma Inc · 2 weeks ago
Research Study Coordinator
Unicon Pharma Inc is focused on clinical studies, and they are seeking a Research Study Coordinator to assist in planning and execution of clinical studies. The role involves ensuring adherence to protocols, GCPs, and FDA regulations while maintaining necessary documentation and tracking items as required.
Responsibilities
Assist in planning and execution of clinical studies, under the close supervision of a Senior Manager (or above) within Clinical Operations, in adherence to the protocol, Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines
Create/maintain spreadsheets to track other items as needed, (e.g. Vendor invoices)
Qualification
Required
Minimum of 1-year relevant experience is required
Working skills in computer applications, such as Microsoft Word, Excel, PowerPoint, and Outlook
Preferred
Veeva experience is a plus
Oncology experience is a plus
Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO), and Contract Research Organization (CRO)
Time spent directly in a medical environment (e.g. as a Study Site Coordinator) is also considered relevant